MAUDE Adverse Event Report: K2M, INC. Driver Height/Angle; Spinal Vertebral Body Replacement Device

Catalog Number	7501-90025
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tips of two capri height expansion drivers deformed intra-operatively.The procedure was completed successfully with no delay and no adverse consequence to the patient.This report captures the second of two height expansion drivers.
Event or Problem Description
Component description (g),component code fda (g),component code imdrf (g) tip,3123,g04129 .

• Brand Name: Driver Height/Angle
• Common Device Name: Spinal Vertebral Body Replacement Device
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, Inc.; 600 hope pkwy se; leesburg VA 20175
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; +1(201)760-8000
• MDR Report Key: 24550783
• Report Number: 3004774118-2026-00081
• Device Sequence Number: 20233305
• Product Code: MQP
• UDI-Device Identifier: 10888857361911
• UDI-Public: 10888857361911
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7501-90025
• Device Lot Number: PCCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 07/06/2026; 07/06/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 08/05/2026; 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown